FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00818345029903
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A3-000012
Catalog number
FG1-A3-000012
Device description
Screwdriver, Reduction
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345029903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345029903008183450299038183450299030818345029903

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080386764
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493421797RIVA Pedicle Screw SystemFG1-15-140550FG1-15-1405502026-05-06
00840493421803RIVA Pedicle Screw SystemFG1-15-140600FG1-15-1406002026-05-06
00840493421810RIVA Pedicle Screw SystemFG1-16-140040FG1-16-1400402026-05-06
00840493421827RIVA Pedicle Screw SystemFG1-16-140045FG1-16-1400452026-05-06
00840493421834RIVA Pedicle Screw SystemFG1-16-140450FG1-16-1404502026-05-06
00840493421841RIVA Pedicle Screw SystemFG1-16-140055FG1-16-1400552026-05-06
00840493421858RIVA Pedicle Screw SystemFG1-16-140060FG1-16-1400602026-05-06
00840493421865RIVA Pedicle Screw SystemFG1-16-140065FG1-16-1400652026-05-06
00840493421872RIVA Pedicle Screw SystemFG1-16-140070FG1-16-1400702026-05-06
00840493421889RIVA Pedicle Screw SystemFG1-16-140075FG1-16-1400752026-05-06
00840493421896RIVA Pedicle Screw SystemFG1-16-140080FG1-16-1400802026-05-06
00840493421902RIVA Pedicle Screw SystemFG1-16-140085FG1-16-1400852026-05-06
00840493421919RIVA Pedicle Screw SystemFG1-16-140090FG1-16-1400902026-05-06
00840493421926RIVA Pedicle Screw SystemFG1-16-140095FG1-16-1400952026-05-06
00840493421933RIVA Pedicle Screw SystemFG1-16-140100FG1-16-1401002026-05-06
00840493421940RIVA Pedicle Screw SystemFG1-16-140110FG1-16-1401102026-05-06
00840493421957RIVA Pedicle Screw SystemFG1-16-140120FG1-16-1401202026-05-06
00840493421964RIVA Pedicle Screw SystemFG1-16-140130FG1-16-1401302026-05-06
00840493421971RIVA Pedicle Screw SystemFG1-16-140140FG1-16-1401402026-05-06
00840493421988RIVA Pedicle Screw SystemFG1-16-140150FG1-16-1401502026-05-06

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M7403030034Discectomy SetSPINEOLOGY INC.LXH2026-05-28
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